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FENIX™ Continence Restoration System Registry

NCT04007250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2019-07-26

No results posted yet for this study

Summary

The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.

Conditions

  • Fecal Incontinence
  • Faecal Incontinence

Interventions

DEVICE

FENIX™ Continence Restoration System

The FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence. The FENIX™ System is comprised of the following components: * FENIX™ System Implant * FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed.

Sponsors & Collaborators

  • Torax Medical Incorporated

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-07
Primary Completion
2019-02-27
Completion
2019-02-27
FDA Device
Yes

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007250 on ClinicalTrials.gov